CTRI Number |
CTRI/2023/05/052307 [Registered on: 04/05/2023] Trial Registered Prospectively |
Last Modified On: |
12/07/2024 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Drug |
Study Design |
Randomized, Parallel Group Trial |
Public Title of Study
|
Role of dexamethasone in nebulized versus intravenous route in prevention of post operative sore throat |
Scientific Title of Study
|
Nebulized Dexamethasone versus intravenous Dexamethasone in prevention of post operative sore throat in patient undergoing endotracheal intubation during general anesthesia |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Debahuti Chatterjee |
Designation |
Junior Resident |
Affiliation |
Kasturba Medical College Manipal |
Address |
Department of Anesthesiology,
Kasturba Medical college Manipal,
Tiger circle road,
Madhavnagar, Manipal , Karnataka
Udupi KARNATAKA 576104 India |
Phone |
7063279142 |
Fax |
|
Email |
chatterjeedebahuti@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Laxmi Shenoy |
Designation |
Associate professor |
Affiliation |
Kasturba Medical College Manipal |
Address |
Department of Anesthesiology
Kasturba Medical college
Manipal,
tiger circle road
Madhav Nagar , Karnataka
Udupi KARNATAKA 576104 India |
Phone |
8073822017 |
Fax |
|
Email |
drlaxmishenoy@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr Shweta Sinha |
Designation |
Assistant Professor |
Affiliation |
Kasturba Medical College Manipal |
Address |
Department of Anesthesiology
Kasturba Medical college
Manipal,
tiger circle road
Madhav Nagar , Karnataka
Udupi KARNATAKA 576104 India |
Phone |
8879056117 |
Fax |
|
Email |
shweta1987.SS95@gmail.com |
|
Source of Monetary or Material Support
|
Kasturba Medical College , Manipal |
|
Primary Sponsor
|
Name |
Kasturba Medical Colleges |
Address |
Kasturba Medical college,
Manipal Karnataka
Pin 576104 |
Type of Sponsor |
Private medical college |
|
Details of Secondary Sponsor
|
|
Countries of Recruitment
|
India |
Sites of Study
|
No of Sites = 1 |
Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
Debahuti Chatterjee |
Kasturba Medical College Manipal |
Department of Anesthesiology,
Main OT complex, Balia’s block, Kasturba Medical college & hospital , Udipi Karnataka
576104
Tiger circle road ,Manipal,
Karnataka Udupi KARNATAKA |
7063279142
chatterjeedebahuti@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
IEC |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Comparator Agent |
Control group |
Patient will not be given intravenous or nebulized Dexamethasone |
Intervention |
group intravenous
|
single dose of intravenous dexamethasone 0.2mg/kg half an prior to induction with general anesthesia |
Comparator Agent |
group nebulized |
single dose of nebulized dexamethasone 0.2mg/kg prior to induction with general anesthesia |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
60.00 Year(s) |
Gender |
Both |
Details |
•Adult patient aged 18-60 years of either gender
•ASA PS grade I/ II scheduled to undergo surgery requiring general anesthesia with duration less than 3hrs
|
|
ExclusionCriteria |
Details |
1. Patient with anticipated difficult airway
2. Patient on steroids
3. Patient on recent history URTI/ LRTI
3.patient requiring more than 2 attempts during intubation
4.patients with history of diabetes mellitus
5. Head neck surgeries
6 Patient in whom Dexamethasone is from surgical side contraindicated |
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
On-site computer system |
Blinding/Masking
|
Participant Blinded |
Primary Outcome
|
Outcome |
TimePoints |
Assessment of post operative sore throat . |
Presence of sore throat and grading will be done at 12 hrs , 24 hrs and 48 hrs |
|
Secondary Outcome
|
Outcome |
TimePoints |
1. To note the presence of cough and hoarseness of voice 2. Pre and post operative blood sugar levels
|
Presence of sore throat and grading will be done at 12 hrs , 24 hrs and 48 hrs |
|
Target Sample Size
|
Total Sample Size="120" Sample Size from India="120"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="138" |
Phase of Trial
|
Phase 4 |
Date of First Enrollment (India)
|
11/05/2023 |
Date of Study Completion (India) |
12/07/2024 |
Date of First Enrollment (Global) |
Date Missing |
Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
|
Years="1" Months="6" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
Recruitment Status of Trial (India) |
Completed |
Publication Details
|
not published in any National or international Journal |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
|
Sore throat is a common postoperative complaint occuring in adults in the post operative period following general anesthesia. Postoperative sore throat can result in cough which can cause strain and increased pain at surgical site . Several pharmacological and non pharmacological methods have been tried to decrease the incidence and severity of post operative sore throat. Dexamethasone is a potent corticosteroid with anti-inflammatory property. In this study we compare the effectiveness of intravenous versus nebulized dexamethasone in preventing post operative sore throat with the least undesirable effects .In this study patients will be assessed a day prior to surgery during the preanesthetic checkup and the patients who will fulfil the inclusion criteria will be included in the study. The randomization will be done by using a computer-generated random number table and the patient will be allocated into one of the three groups. In the first group patient will receive intravenous dexamethasone (0.2mg/kg of body weight) half an hour before induction of anesthesia. The second group will be given nebulization with dexamethasone (0.2mg/kg of body weight with 3ml of NS) half an hour before induction of anesthesia. The third group will be a control group who will not be given either intravenous or nebulized dexamethasone. All patient taken up for surgery will be premedicated as per standard protocol. On the day of the surgery, patient will be taken to pre operative area where noninvasive blood pressure, pulse oximeter would be attached and vitals will be noted. Preoperatively GRBS will also be noted while securing intravenous cannula. Patient will be nebulized with dexamethasone or be given intravenous dexamethasone according to randomization 30 min prior to induction. The patient will be then shifted to operation theatre and standard ASA monitors will be attached. Anesthesia will be induced according to the respective anesthetist discretion.. Airway will be secured with PVC portex tubes of appropriate sizes (size of 7mm and 8mm internal diameter for females and males respectively) . The Cormack- Lehane grade would be noted in all patient during laryngoscopy , patient with grade IIb and above would be excluded. The cuff would be inflated with room air and cuff pressure would be kept at 25 -30 cms of water intraoperatively .The ETT tube placement would be confirmed with the appearance of square wave end tidal capnography. Anesthesia would be maintained with isoflurane (1-1.5%)in oxygen- air mixture. Mechanical ventilation would be adjusted to maintain partial pressure of carbon dioxide between 30- 35mmHg. Cuff pressure would be monitored with cuff manometer every 30 min and would be maintained at 25 –30 cms of water. Paracetamol infusion of 15mg/kg and fentanyl boluses will be administered for intraoperative pain. For post-operative pain all patients will receive paracetamol infusion of 15mg/kg 8th hourly. At the end of the surgery, gentle oral suctioning would be done and anesthesia would be reversed with glycopyrrolate 0.01mg/kg and neostigmine 0.05mg/kg. Any cough/ blood over the ET tube during extubation will be noted. Pre extubation GRBS will be noted to rule out any systemic absorption causing increase in blood sugars. |